Notified Bodies under the MDR and IVDR: The Designated List, NANDO, Scope Codes and How to Choose One

A notified body takes part in the conformity assessment of MDR classes IIa, IIb and III, of the sterile, measuring and reuse aspects of classes Is, Im and Ir, and of IVDR classes B, C and D and sterile class A devices. Other MDR class I devices and non-sterile IVDR class A devices are self-declared by their manufacturers.

This page explains the legal basis in both regulations, the dated counts and survey figures, how a NANDO entry is read, the scope codes that limit each designation, the checks before choosing a body, and how designation and monitoring work. It names no notified body and ranks none.

What Is a Notified Body?

A notified body is a conformity assessment body designated in accordance with the MDR (Article 2(42)) or the IVDR (Article 2(34)), and a conformity assessment body is one that performs third-party conformity assessment activities, including calibration, testing, certification and inspection (MDR Article 2(41), IVDR Article 2(33)).

Both acts are regulations, directly applicable in every member state without national transposition. They entered into force on 25 May 2017; the MDR has applied since 26 May 2021 and the IVDR since 26 May 2022. Designation is granted per regulation, so a body holds an MDR designation, an IVDR designation or both, and each is listed under its own legislation in NANDO. How notified bodies fit into the wider framework of the EU MDR and IVDR is explained on the home page.

The Legal Basis: MDR Articles 35 to 50 and IVDR Articles 31 to 46

MDR Articles 35 to 50 (Chapter IV) and IVDR Articles 31 to 46 set out who designates notified bodies, what they must meet, and how they are designated, numbered, monitored, coordinated and publish their fees. The articles run in the same order in both regulations: the authorities responsible for notified bodies come first (MDR Article 35, IVDR Article 31) and the lists of standard fees close the chapter (MDR Article 50, IVDR Article 46).

The requirements themselves sit in Annex VII of each regulation. Four implementing and delegated acts complete the chapter. Implementing Regulation (EU) 2017/2185 lists the scope codes. Delegated Regulations (EU) 2023/502 and 2023/503 set the cycle of complete re-assessment. Implementing Regulation (EU) 2026/977 lays down the uniform application of Annex VII under MDR Article 36(3) and IVDR Article 32(3) and applies from 25 February 2027.

Which Devices Need a Notified Body

A notified body is involved for MDR classes IIa, IIb and III, for the sterile, measuring and reuse aspects of classes Is, Im and Ir, and for IVDR classes B, C and D and the sterile aspects of sterile class A; other MDR class I devices and non-sterile IVDR class A devices are self-declared. Where a body is needed, the manufacturer chooses it, does not lodge parallel applications with two bodies for the same procedure and discloses earlier applications that were withdrawn or refused (MDR Article 53; IVDR Article 49 is the counterpart). The table shows the involvement by class as of 6 November 2026.

Notified Bodies in Detail: Certificates, Fees and Timelines

Two detailed pages cover what a notified body issues and what it charges: the certificate types and their validity, and the standard fee lists with the maximum timelines that apply from 25 February 2027. The table lists both pages with the articles behind them.

The Designated List: How Many Bodies Each Regulation Has

The Commission's overview of notified bodies dated 30 June 2026 counts 52 bodies designated under the MDR and 19 under the IVDR, against 67 MDR and 25 IVDR applications for designation. NANDO, not a third-party list, is the place to check a body, because publication there is the step that makes a designation valid (see the notification steps below).

The count changes with every new designation, suspension or withdrawal, so a figure is always quoted with its date and its source. The official lists are the NANDO list of MDR notified bodies and the NANDO list of IVDR notified bodies, next to the Commission's notified-bodies page. The table combines the overview with the 20th notified-body survey; both are dated sources, and neither is a count for any later date.

What the Commission Survey Shows

The Commission's 20th notified-body survey (data to 28 February 2026, published 2 July 2026) counts 31,902 MDR applications, 20,698 signed written agreements and 989 refusals, and 3,723 IVDR applications, 1,813 written agreements and 145 refusals. The figures are cumulative from each body's designation, so they measure the whole MDR and IVDR period up to that cut-off date, not one year.

The survey also gives the main reasons why MDR applications are refused. An application outside the scope of the body's designation accounts for 30 % of refusals, and an incomplete application for 25 %. Of the 52 MDR notified bodies, 14 report that more than half of the submissions they receive are complete. Both reasons can be checked before an application is lodged, and they lead directly to the second and fourth checks in the section on choosing a body.

How to Read a NANDO Entry

NANDO (New Approach Notified and Designated Organisations) is the Commission's register of notified bodies in the Single Market Compliance Space, and its MDR and IVDR lists are reached by filtering on the legislation, Regulation (EU) 2017/745 or Regulation (EU) 2017/746. Bodies are notified there under several Union acts, so the legislation filter is the first step.

The two filtered lists answer the question of where to find a list of notified bodies for medical devices and IVDs. A body designated under both regulations appears in both lists, each with its own notification. A notification under one of the repealed directives is not an MDR or IVDR designation, so an entry is read only under the legislation that applies to the device.

The Four-Digit Identification Number

The Commission assigns each notified body one identification number, the same under every Union act it is notified for, and bodies notified under Directives 90/385/EEC and 93/42/EEC kept their number under the MDR (MDR Article 43; IVDR Article 39). The list of numbers is public in NANDO.

The four-digit number follows the CE marking where a notified body took part in the conformity assessment, and it also appears in any promotional material that mentions that the device meets the CE requirements (MDR Article 20(5), IVDR Article 18(5)). Self-declared devices carry no number next to the mark. The full marking rules are on the page on CE marking for medical devices and IVDs.

Status and Dates

Each notification in NANDO carries a status, an approval date and, where one is set, an end date, and these fields are read for the regulation that applies to the device. Where NANDO and another list differ, NANDO and the Commission's overview are the sources to follow.

Scope Codes under Implementing Regulation (EU) 2017/2185

Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 (OJ L 309, 24.11.2017, p. 7), in force since 25 November 2017, lists the codes that define the scope of each notified body's designation, MDR codes in Annex I and IVDR codes in Annex II. The text is published on EUR-Lex as Implementing Regulation (EU) 2017/2185.

A body is designated for a set of codes, and its designation covers devices within that scope only. Two notes explain the codes: MDCG 2019-14 (December 2019) for the MDR codes and MDCG 2021-14 (July 2021) for the IVDR codes; neither is legally binding. Both notes sit in the register of MDCG guidance by topic.

MDR Code Families

Annex I of Implementing Regulation (EU) 2017/2185 groups the MDR codes into four families: MDA for active devices, MDN for non-active devices, MDS for devices with specific characteristics and MDT for technologies or processes. Each code carries its family letters followed by a number, as in MDA 0101 or MDS 1002. A conformity assessment body that applies for MDR designation states the codes it seeks in the applied-for scope form of MDCG 2021-17 (July 2021).

IVDR Code Families

Annex II of Implementing Regulation (EU) 2017/2185 groups the IVDR codes into five families: IVR codes by design and intended purpose, the IVS, IVT and IVP families, and IVD horizontal codes. The IVDR codes follow the same pattern of family letters and a number, as in IVR 0201 or IVD 4003. A body applying for IVDR designation states its applied-for scope in the MDCG 2021-18 form (July 2021).

Codes Covered by Few Bodies

The Commission's note on the coverage of designation codes (June 2025) lists the codes that 10 or fewer notified bodies cover. The codes in the note, by regulation, are these:

• MDR: MDA 0101, MDA 0102, MDA 0103, MDA 0104 and MDS 1002.
• IVDR: IVR 0101 to IVR 0106 (blood grouping), IVR 0201 and IVR 0202 (tissue typing), IVP 3009 and IVD 4003.

For a device under one of these codes, the scope check narrows the choice of body before any other question is asked.

How to Choose a Notified Body

Choosing a notified body starts with the register, not with a name: the body must be designated under the regulation that applies, its scope codes must cover the device, and it must be able to take the application on. The manufacturer's free choice is described above; a later move to another body is a voluntary change under MDR Article 58 or IVDR Article 53, covered on the certificates page.

Four Checks Before You Apply

Four checks separate a body that can assess a device from one that cannot, and each rests on a public source or on the body's own answer. They are listed below in the order in which they are made.

1. Confirm the designation under the right regulation in the NANDO list for Regulation (EU) 2017/745 or Regulation (EU) 2017/746, and read its status, approval date and any end date.
2. Match the scope codes of Implementing Regulation (EU) 2017/2185 to the device (an application outside the scope of designation is the most common MDR refusal reason).
3. Ask about capacity: MDCG 2022-14 (August 2022) addresses notified-body capacity and the availability of devices, and the codes covered by 10 or fewer bodies are listed above. Capacity, waiting times and working languages are questions to put to each body. The language requirements of MDR Article 41 and IVDR Article 37 apply to the documents of the designation procedure.
4. Prepare a complete application, since an incomplete one is the second refusal reason; what the file contains is set out under MDR and IVDR technical documentation.

Each body publishes its own list of standard fees (MDR Article 50, IVDR Article 46).

Application Deadlines Tied to a Notified Body

For legacy IVDs the only notified-body deadlines still open on 6 November 2026 are those for self-declared class B and sterile class A devices: a formal application by 26 May 2027 and a signed written agreement by 26 September 2027 (IVDR Article 110(3c)(e)(iii) and (f)(iii)), for placing on the market until 31 December 2029. The IVDR class C agreement date of 26 September 2026 has passed.

The MDR conditions have passed too: a quality management system and a formal application by 26 May 2024 and a written agreement by 26 September 2024 (MDR Article 120(3c)). They decide whether a legacy device stays on the market until 31 December 2027 (class III and class IIb implantable, except the listed items) or 31 December 2028 (all others). The table shows both regulations as of 6 November 2026.

What Annex VII Requires of Every Notified Body

Annex VII of each regulation sets the organisational, quality-management, resource and process requirements a notified body must meet, and it bars the body and its staff from offering consultancy services to the manufacturers it assesses (Section 1.2.3(d) and (e), with a three-year cooling-off under Section 1.2.4). The same annex requires fees on fair and reasonable terms that take small and medium-sized enterprises into account (MDR Annex VII Section 1.2).

Under Section 1.6.2 of Annex VII in both regulations, the body "shall take into consideration" guidance and best practice documents, so MDCG guidance carries weight in an assessment. The process with a manufacturer starts with a formal application and a written agreement, and refusals are visible to other notified bodies through EUDAMED (MDR Annex VII Section 4.3). Notified bodies enter their certificates in the Notified Bodies and Certificates module, whose use has been mandatory since 28 May 2026; that module is part of EUDAMED under the MDR and IVDR.

How a Body Becomes Designated

A conformity assessment body applies for designation to the authority responsible for notified bodies (MDR Articles 35 and 38; IVDR Articles 31 and 34), and the application runs through a joint assessment, a recommendation of the Medical Device Coordination Group and a notification to the Commission and the member states. MDCG 2022-13 rev.1 (June 2024) explains designation, re-assessment and notification, and MDCG 2021-15 rev.1 and MDCG 2021-16 rev.1 (January 2025) are the application forms for the MDR and the IVDR. The table gives the MDR periods; the IVDR articles are named without periods.

The Joint Assessment and the Coordination Group Recommendation

Under MDR Article 39 the authority checks completeness within 30 days, a joint assessment team is appointed within 14 days and reviews the documents within 90 days, diverging opinions are documented within 30 days of the on-site assessment, the team's final opinion follows within 21 days and the coordination group recommends within 42 days. The recommendation is made on the draft designation before any notification.

IVDR Article 35 sets the corresponding procedure for IVDR designations. The designating authority is national: in Germany it is the ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, the federal states' central authority for health protection regarding medicinal products and medical devices), which designates and monitors notified bodies. The German authorities and national law are covered on the page on MDR and IVDR in Germany.

Notification, Objections and Publication in NANDO

After the recommendation the member state notifies the body, the Commission and the other member states may object within 28 days (MDR Article 42(6)), an objection goes to the coordination group within 10 days for an opinion within 40 days (Article 42(7)), and the designation becomes valid the day after its publication in NANDO (Article 42(11)). IVDR Article 38 is the counterpart for IVDR designations.

Monitoring, Re-Assessment and Changes to a Designation

A designated body informs its authority of relevant changes within 15 days, is re-assessed at least once a year with an on-site audit and undergoes a complete re-assessment every five years (MDR Article 44(1), (4) and (10); IVDR Article 40, with the five-year rule in Article 40(10)), and the authorities themselves undergo peer review every third year (MDR Article 48(2)). The five-year cycle comes from Delegated Regulations (EU) 2023/502 (MDR) and 2023/503 (IVDR), in force since 11 March 2023. Three further procedures complete the oversight: review of a body's assessment of technical documentation (MDR Article 45, IVDR Article 41), challenge to its competence (MDR Article 47, IVDR Article 43) and coordination in the Notified Body Coordination Group for medical devices, NBCG-Med (MDR Article 49, IVDR Article 45).

Pending: Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026, with past procedural events that include a draft report dated 30 June 2026; it is not law. The proposal would cut notified-body fees for micro and small enterprises and for orphan devices, make certificates not limited in time with periodic reviews, and allow remote audits. The proposal is listed with every adopted act under MDR and IVDR amendments.

Certificates When a Designation Is Suspended or Withdrawn

When a designation is withdrawn, the certificates the body issued stay valid for 9 months, a period that can be extended by 3 months at a time up to 12 months in total (MDR Article 46(9)). A body that plans to cease its activities announces it one year ahead (Article 46(3)), a suspension lasts at most one year and can be renewed once (Article 46(4)), and the body informs the manufacturers concerned within 10 days (Article 46(5)). IVDR Article 42 is the counterpart for IVDR designations.

Other Bodies in the Certification Process

A notified body is the only body that issues MDR and IVDR certificates, while other bodies certify management systems or give opinions within its procedure. The two questions below separate these roles.

Does a Certification Body Count as a Notified Body?

No: an ISO 13485 certificate comes from a certification body and is not an MDR or IVDR certificate, while a notified body issues EU quality management system certificates (MDR Annex XII Chapter I Section 4(b)). The standard's role in both regulations is set out under ISO 13485 under the EU MDR and IVDR.

Expert Panels, Reference Laboratories and Medicines Authorities

Three kinds of bodies take part in some notified-body procedures without issuing certificates.

• Expert panels: the clinical evaluation consultation of MDR Article 54 for class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, and the performance evaluation consultation (IVDR Article 48(6)) for class D; see expert panels under the MDR and IVDR.
• EU reference laboratories: verification for class D IVDs where a laboratory is designated (IVDR Article 100); see EU reference laboratories for class D IVDs.
• Medicines authorities or the European Medicines Agency: consultation under Annex IX Section 5.2 of the MDR and of the IVDR.